nogapendekin alfa inbakicept-pmln (Anktiva): FDA status

Approved Approved Oct 14, 2026. Indication: BCG unresponsive high grade papillary only non muscle invasive bladder cancer. Company: ImmunityBio (Altor BioScience, LLC).

Regulatory history

• Jan 6, 2027: Decision date set. FDA accepted sBLA for Anktiva plus BCG in BCG unresponsive NMIBC with papillary disease and assigned PDUFA target action date of January 6 2027 businesswire.com
• Oct 14, 2026: Label expanded. FDA expanded Anktiva plus BCG approval to adults with BCG-unresponsive high-grade papillary-only NMIBC, first approved therapy for this group. fda.gov
• May 19, 2026: FDA accepted for review. FDA accepted supplemental BLA for Anktiva plus BCG in BCG unresponsive NMIBC with papillary disease, PDUFA set for January 6 2027 Business Wire
• May 2, 2025: Complete response letter. ImmunityBio received a Refusal to File letter from FDA for its sBLA despite prior guidance to submit, and is requesting an urgent meeting. ImmunityBio

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